Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease

May 16, 2026 updated by: Stephanie B. Seminara, MD

The objective of this protocol is to use a case-control paradigm to compare the response to an intravenous administration of kisspeptin in individuals with and without post-covid-19 syndrome. The study subjects will receive a single bolus of kisspeptin.

This study will utilize the technique of frequent blood sampling (q10 minutes) to provide detailed neuroendocrine characterization of endogenous LH secretion before and after kisspeptin administration. This frequency of blood sampling is required to define the features of LH pulses.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Delivery of Interventions:

  • 1-2 hours of q10 minute blood sampling
  • Administration of a single kisspeptin bolus in a dosing range of 0.313 - 13.19 μg/kg

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Female (ages 18-45 years) or Male (ages 18-60 years)
  • Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)
  • Hemoglobin no less than 0.5 g/dL below the lower limit of the sex specific reference range
  • No current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and its method of administration
  • For women, negative serum hCG pregnancy test
  • For cases, diagnosis of post-covid-19 syndrome
  • For controls, history of prior covid infection but no diagnosis of post-covid-19 syndrome

Exclusion Criteria

  • Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol
  • Excessive alcohol consumption (>10 drinks/week)
  • Active use of illicit drugs
  • For women,
  • Pregnant
  • Trying to become pregnant during protocol participation
  • Breast feeding
  • History of any of the following: bilateral oophorectomy (ovaries were removed), breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kisspeptin administration
Single bolus of kisspeptin
Drug: Kisspeptin 112-121
Single bolus of kisspeptin
Other Names:
  • Metastin 45-54

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in mean luteinizing hormone (LH) amplitude between cases and controls
Time Frame: Day of study visit (one to two hours)
Difference between cases and controls of mean LH amplitude in response to kisspeptin
Day of study visit (one to two hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stephanie B. Seminara, MD

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2026

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2030

Study Registration Dates

First Submitted

November 3, 2025

First Submitted That Met QC Criteria

November 3, 2025

First Posted (Actual)

November 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 565179
  • R37HD043341 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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